Drug Safety Scientist, Global Pharmacovigilance
Core
Performs pharmacovigilance activities, safety signal detection, and prepares regulatory safety documents for medical devices and pharmaceuticals.
Role type
Drug Safety Scientist (Global Pharmacovigilance)
Builds
Aggregate safety reports (PSURs/PBRERs, DSURs), risk management plans, and regulatory submissions.
Domain
Healthcare / Medical Technology / Pharmacovigilance
Required skills
Pharmacovigilance, Safety signal detection, Regulatory document authoring, Data analytics, Medical review of case safety reports, Knowledge of FDA/EU/ICH guidelines, Safety systems (Argus, Veeva)
Preferred skills
Medical writing, AI and digital tools for data analysis, PV regulations expertise
Technologies
Argus, Veeva
Responsibilities
Perform safety signal detection and evaluation using analytical tools; Author and coordinate high-quality safety content for clinical and post-marketing documents; Gather and evaluate scientific information for reference safety information; Collaborate with Medical Directors and regulatory authorities on safety questions; Perform Medical Reviewer of Individual Case Safety Reports; Assist in creating and maintaining standard operating procedures.
Seniority
Mid-level, hands-on IC